Qualigen
     

 
 
Design and development of formulation and pharmaceutical specialties
The Pharmaceutical Development Department is specialized in the development of different pharmaceutical forms of generics from laboratory-scale and validation batches up to full-scale commercial manufacturing, according to the current regulatory standards, with subsequent patent applications of formulations.
 

As a common practice our Pharmaceutical Development team screens an extensive set of potential formulations and in critical cases, several developments are conducted in parallel to guarantee the selection of the most appropriate and patentable final form.
The formulation capabilities cover conventional and advanced processing technologies, including a validated and GMP certified Pilot Plant of pharmaceutical technology for pilot-scale batch production.
In our vertically integrated development process from design and production of API to registration of generic specialties the Biological Development Department plays a key role in designing, monitoring and analyzing bioequivalence studies and their subsequence results. For these activities we collaborate with the most prestigious CRO and Hospitals in Europe.
 
 
 
 
None of the products will be supplied to countries in which this could be in conflict with the existing patents. However, the final responsibility lies exclusively with the buyer.
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